Viewing Study NCT00236288



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Study NCT ID: NCT00236288
Status: COMPLETED
Last Update Posted: 2007-10-31
First Post: 2005-10-07

Brief Title: A Feasibility Study of Smoking Cessation Program in Radiation Oncology
Sponsor: Indiana University School of Medicine
Organization: Indiana University

Study Overview

Official Title: A Feasibility Study of Smoking Cessation Program in Radiation Oncology
Status: COMPLETED
Status Verified Date: 2007-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation program for radiation oncology patients and their familiescompanions
Detailed Description: There is overwhelming evidence to support tobacco use as the number one cause of preventable cancer and cardiovascular death Smoking is responsible for at least 30 of all cancer deaths and nearly 90 of lung cancer deaths There is robust phase III randomized data to show improved smoking cessation with both behavioral strategies as well as pharmacologic interventions such as bupropion

Despite significant evidence showing survival toxicity and quality of life detriments in cancer patients who continue smoking after diagnosis roughly one third of cancer patients continue to use tobacco There is a relative paucity of data regarding smoking cessation programs in cancer patient populations Several single institution as well as cooperative group ECOG efforts have been published with varying results However to date there are no published reports on the success of pharmacologic smoking cessation interventions in cancer patients

Patients undergoing definitivecurative radiotherapy often receive daily treatment over the course of three to eight weeks They are often accompanied and supported daily by family members or companions many of whom smoke This represents a huge exposure to the health care system and a unique opportunity for intensive intervention in both cancer patients and their familiescompanions during their daily routine of radiotherapy To date there is no published report on intensive tobacco cessation intervention concurrent with radiotherapy in cancer patients and their families or companions

We propose a feasibility study of an intensive tobacco cessation program to be delivered to radiation oncology patients andor their familycompanions concurrent with planned radiotherapy This program will feature an intensive behavioral intervention as well as the pharmacologic agent bupropion

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Walther Cancer Institute Inc None None None